Development and Validation of UV Spectrophotometric method for estimation of Lafutidine in bulk and Pharmaceutical dosage form

A simple, rapid, accurate, precise, sensitive and economical UVspectrophotometric method has been developed for estimation of Lafutidine from bulk and pharmaceutical formulation. The max of Lafutidine in 0.1N HCL was found to be 286 nm. The parameters linearity, precision, accuracy, limit of detection and limit of quantitation, ruggedness were studied according to International Conference on Harmonization guidelines. The drug follows linearity in the concentration range 5- 50μg/ml with correlation coefficient value 0.9995. The proposed method was applied to pharmaceutical formulation and % amount of drug estimated 99.19 % was found in good agreement with the label claim. The accuracy of the method was checked by recovery experiment performed at three different levels i.e., 80%, 100% and 120 %. The % recovery was found to be in the range 99.57%– 99.91%. The low values of % R.S.D. are indicative of the accuracy and reproducibility of the method. The precision of the method was studied as an intra-day, inter-day variations and repeatability. The % R.S.D. value less than 2 indicate that the method is precise. The above method was a cost-effective quality- control tool for routine analysis of Lafutidine in bulk and in pharmaceutical dosage form.

Author(s): Parekh Ravishkumar R, Patel Pinkal H, Patel Chinmay D, Patel Krupali S, Patel Hardik N

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